UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010120 |
|---|---|
| Receipt number | R000011855 |
| Scientific Title | A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine |
| Date of disclosure of the study information | 2013/02/26 |
| Last modified on | 2016/11/04 14:16:27 |
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Basic information
Public title
A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine
Acronym
Preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative
Scientific Title
A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine
Scientific Title:Acronym
Preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the safety of preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Acute toxicity of organ at risks
Key secondary outcomes
Primary response rate by recommended dose in 6 months after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2 weeks Carbon ion radiotherapy: 36.8 GyE / 8 fractions
Chemotherapy: weekly gemcitabine 1000 mg / m2 for 3 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Union for International Cancer Control (UICC) StageI- IIB invasive ductal carcinomas of the pancreas
2)Pathologically confirmed invasive ductal carcinomas
3)Patients with no histories of prior chemotherapy or pelvic radiotherapy for pancreasl cancer
4)Tumor size <= 15cm
5)The tumor had to be grossly measurable.
6)Age <= 80 years
7)Performance status 0 - 1
8)Normal organ function
WBC >= 4000/mm3
neutrophil>= 2000/mm3
Hb >= 9.0g/dl
Plt>= 100,000/mm3
T-Bil.<= 3.0mg/dl,
AST(GOT) and ALT(GPT) <= 100IU/dl
Cre <= 1.2mg/dl
9)Written informed consent
Key exclusion criteria
1)History of abdominal radiotherapy
2)Metallic stent for obstructive jaundice
3)Digestive tracts invasion
4)Severe complicating illness
5)Histoly of other malignancies within 2 years
6)Active and Severe infection
7)medical, psychological or others reason that primary doctor think ineligible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yamada |
Organization
National Institute of Radiological Sciences
Division name
Research Center Hospital for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL
043-206-3306
yamada.shigeru@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Yamada |
Organization
National Institute of Radiological Sciences
Division name
Research Center Hospital for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL
043-206-3306
Homepage URL
http://www.nirs.go.jp/hospital/index.shtml
yamada.shigeru@qst.go.jp
Sponsor or person
Institute
Research Center Hospital for Charged Particle Therapy
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 26 | Day |
Last modified on
| 2016 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011855
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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